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Pharmaceutical Sector Country Profile Questionnaire.
Section 0 General Info
0.01 Contact Info
0.01.01 Country (precoded) Lebanon-RV
0.01.02 Name coordinator Rasha Hamra
0.01.03 Address (Street, City) Museum Area, Mansour Building, Beirut-Lebanon
0.01.04 Phone number 00961-1-615711
0.01.05 Email address rashahamra@yahoo.com
0.01.06 Web address www.moph.gov.lb
0.01.07 Institution Ministry of Health
Pharmaceutical Sector Country Profile Questionnaire.
Section 1 Health and Demographic data
1.00 Respondent Information Section 1
1.00.01 Name of person responsible for filling out Survey section 1
Hilda Harb
1.00.02 Phone number
1.00.03 Email address hilda_harb@yahoo.com
1.00.04 Other respondents for filling out this section
1.01 Demographic and Socioeconomic Indicators
Core questions (click here for help)
Year Source
1.01.01 Population, total (,000) 4,189 2010 MOH-Statistical Bulletin
1.01.02 Population growth rate (Annual %) 1,8 2010 MOH-Statistical Bulletin
1.01.03 Total Gross Domestic Product (GDP) (millions US$)
34,925 2009 Ministry of Finance Data
1.01.04 GDP growth (Annual %) 8.00 2009 World Bank data
1.01.05C GDP per capita (US$ current exchange rate)
8,337.31 2009
1.01.06 Comments and References
Supplementary questions (click here for help)
Year Source
1.01.07S Population < 15 years (% of total population)
25 2010 MOH-Statistical Bulletin
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1.01.08S Population > 60 years (% of total population)
13.4 2010 MOH-Statistical Bulletin
1.01.09S Urban population (% of total population)
87 2008 WHS
1.01.10S Fertility rate, total (Births per woman) 1.8 2008 WHS
1.01.11S Population living with less than $1.25/day (international PPP) (%)
1.01.12S Population living below nationally defined poverty line (%)
1.01.13S Income share held by lowest 20% of the population (% of national income)
1.01.14S Adult literacy rate, 15+ years (% of relevant population)
90 2008 WHS
1.01.15S Comments and References
1.02 Mortality and Causes of Death
Core questions (click here for help)
Year Source
1.02.01 Life expectancy at birth for men (Years)
70 2008 WHS
1.02.02 Life expectancy at birth for women (Years)
74 2008 WHS
1.02.03 Infant mortality rate, between birth and age 1 (/1,000 live births)
9 2009 MICS 3
1.02.04 Under 5 mortality rate (/1,000 live births)
10 2009 MICS 3
1.02.05 Maternal mortality ratio ( /100,000 live births)
26 2008 National Study adopted by WHO
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1.02.06 Please provide a list of top 10 diseases causing mortality
Yes 2009 Hospital Based mortality surveillance done by MOH
1.02.06.01 Disease 1 Cardiac Diseases
1.02.06.02 Disease 2 Cerebro-Vascular Disease
1.02.06.03 Disease 3 Injuries
1.02.06.04 Disease 4 Trachea, Bronchus and Lung Cancer
1.02.06.05 Disease 5 Respiratory Diseases
1.02.06.06 Disease 6 Perinatal Conditions
1.02.06.07 Disease 7 Septicemia
1.02.06.08 Disease 8 Pneumonia
1.02.06.09 Disease 9
1.02.06.10 Disease 10
1.02.07 Please provide a list of top 10 diseases causing morbidity
Yes
1.02.07.01 Disease 1
1.02.07.02 Disease 2
1.02.07.03 Disease 3
1.02.07.04 Disease 4
1.02.07.05 Disease 5
1.02.07.06 Disease 6
1.02.07.07 Disease 7
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1.02.07.08 Disease 8
1.02.07.09 Disease 9
1.02.07.10 Disease 10
1.02.08 Comments and References
Supplementary questions (click here for help)
Year Source
1.02.09S Adult mortality rate for both sexes between 15 and 60 years (/1,000 population)
160 2008 WHS
1.02.10S Neonatal mortality rate ( /1,000 live births)
8 2008 WHS
1.02.11S Age-standardized mortality rate by non-communicable diseases (/100,000 population)
715 2004 WHS
1.02.12S Age-standardized mortality rate by cardiovascular diseases (/100,000 population)
435 2009 WHS
1.02.13S Age-standardized mortality rate by cancer ( /100,000 population)
90 2009 WHs
1.02.14S Mortality rate for HIV/AIDS (/100,000 population)
1.02.15S Mortality rate for tuberculosis (/100,000 population)
1.3 2008 WHS
1.02.16S Mortality rate for Malaria (/100,000 population)
0 2006 WHS
1.02.17S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 2 Health Services
2.00 Respondent Information Section 2
2.00.01 Name of person responsible for filling out this section of the instrument
2.00.02 Phone number
2.00.03 Email address
2.00.04 Other respondents for filling out this section
2.01 Health Expenditures
Core questions (click here for help)
Year Source
2.01.01.01 Total annual expenditure on health (millions NCU)
3,783,856.69 2008 NHA data
2.01.01.02 Total annual expenditure on health (millions US$ average exchange rate)
2,510.02 2008 NHA data
2.01.02C Total health expenditure as % of Gross Domestic Product
2.01.03.01C Total annual expenditure on health per capita (NCU)
2.01.03.02C Total annual expenditure on health per capita (US$ average exchange rate)
2.01.04.01 General government annual expenditure on health (millions NCU)
1,853,861.48 2008 NHA data
2.01.04.02 General government annual expenditure on health (millions US$ average exchange rate)
1,229.76 2008 NHA data
2.01.05 Government annual expenditure on health as percentage of total government budget (% of total government budget)
12.39 2008 NHA data
8.58
902,207.13
598.48
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2.01.06C Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health)
2008 NHA data
2.01.07.01C Annual per capita government expenditure on health (NCU)
2.01.07.02C Annual per capita government expenditure on health (US$ average exchange rate)
2.01.08C Private health expenditure as % of total health expenditure (% of total expenditure on health)
2.01.09 Population covered by a public health service or public health insurance or social health insurance, or other sickness funds of total population)
50 2011 MOH
2.01.10 Population covered by private health insurance (% of total population)
8 2011 MOH
2.01.11.01 Total pharmaceutical expenditure (millions NCU)
2.01.11.02 Total pharmaceutical expenditure (millions US$ current exchange rate)
2.01.12.01C Total pharmaceutical expenditure per capita (NCU)
2.01.12.02C Total pharmaceutical expenditure per capita (US$ current exchange rate)
2.01.13C Pharmaceutical expenditure as a % of GDP (% of GDP)
2.01.14C Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure)
442,027.06
48.99
293.22
51.01
PREFILL CALC
PREFILL CALC
PREFILL CALC
PREFILL CALC
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2.01.15.01 Total public expenditure on pharmaceuticals (millions NCU)
2.01.15.02 Total public expenditure on pharmaceuticals (millions US$ current exchange rate)
2.01.16C Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%)
2.01.17.01C Total public expenditure on pharmaceuticals per capita (NCU)
2.01.17.02C Total public expenditure on pharmaceuticals per capita (US$ current exchange rate)
2.01.18.01 Total private expenditure on pharmaceuticals (millions NCU)
2.01.18.02 Total private expenditure on pharmaceuticals (millions US$ current exchange rate)
2.01.19 Comments and References
Supplementary questions (click for help)
Year Source
2.01.20S Social security expenditure as % of government expenditure on health (% of government expenditure on health)
48.28 2008 NHA data
2.01.21S Market share of generic pharmaceuticals [branded and INN] by value (%)
2.01.22S Annual growth rate of total pharmaceuticals market value (%)
2.01.23S Annual growth rate of generic pharmaceuticals market
PREFILL CALC
PREFILL CALC
PREFILL CALC
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value (%)
2.01.24S Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health)
78.32 2008 NHA data
2.01.25S Premiums for private prepaid health plans as % of total private health expenditure (% of private expenditure on health)
17.30 2008 NHA data
2.01.26S Comments and References
2.02 Health Personnel and Infrastructure
Core questions (click for help)
Year Source
2.02.01 Total number of pharmacists licensed/registered to practice in your country
6,195 2011 MOH Statistics
2.02.02C Pharmacists per 10,000 population
2.02.03 Total number of pharmacists working in the public sector
2.02.04 Total number of pharmaceutical technicians and assistants
2.02.05 A strategic plan for pharmaceutical human resource development is in place in your country?
Yes No 2011 MOH
2.02.06 Total number of physicians 12,259 2011 MOH Statistics
2.02.07C Physicians per 10,000 pop
2.02.08 Total number of nursing and
midwifery personnel 2011 MOH
Statistics
2.02.09C Nurses and midwives per 10,000 pop
9.79
28.04
11.25
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2.02.10 Total number of hospitals 148 2011 MOH Statistics
2.02.11 Number of hospital beds per 10,000 pop
2.02.12 Total number of primary health care units and centers
867 2011 MOH Statistics
2.02.13 Total number of licensed pharmacies
2,477
2.02.14 Comments and References 2.02.10: Total number of hospitals: 148, [Short Stay Private: 121 (11,000Beds), Short Stay Public: 27 (1, 500Beds)]
2.02.12: 747 Dispencries, 120 PHC
Supplementary questions (click here for help)
Year Source
2.02.15S Starting annual salary for a newly registered pharmacist in the public sector (NCU)
2.02.16S Total number of pharmacists who graduated (first degree) in the past 2 years in your country
2.02.17S Are there accreditation requirements for pharmacy schools?
Yes No 2011 MOH
2.02.18S Is the Pharmacy Curriculum regularly reviewed?
Yes No 2011 MOH
2.02.19S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 3 Policy issues
3.00 Respondent Information Section 4
3.00.01 Name of person responsible for filling out this section of the instrument
Dr. Walid Ammar
3.00.02 Phone number
3.00.03 Email address mphealth@cyberia.net.lb
3.00.04 Other respondents for filling out this section
3.01 Policy Framework
Core questions (click here for help)
Year Source
3.01.01 National Health Policy exists. If yes, please write year of the most recent document in the "year" field.
Yes No 2007 MOH
3.01.02 National Health Policy Implementation plan exists. If yes, please write the year of the most recent document in the "year"
Yes No 2007 MOH
3.01.03 Please provide comments on the Health policy and its implementation plan
3.01.04 National Medicines Policy official document exists. If yes, please write the year of the most recent document in the "year" field.
Yes No 2007 MOH
3.01.05 Group of policies addressing pharmaceuticals exist.
Yes No 1994 Pharmacy Law
3.01.06 National Medicines Policy covers the following components:
Yes
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3.01.06.01 Selection of Essential Medicines Yes
3.01.06.02 Medicines Financing Yes
3.01.06.03 Medicines Pricing Yes
3.01.06.04 Medicines Procurement Yes
3.01.06.05 Medicines Distribution Yes
3.01.06.06 Medicines Regulation Yes
3.01.06.07 Pharmacovigilance Yes
3.01.06.08 Rational Use of Medicines Yes
3.01.06.09 Human Resource Development Yes
3.01.06.10 Research Yes
3.01.06.11 Monitoring and Evaluation Yes
3.01.06.12 Traditional Medicine Yes
3.01.07 National medicines policy implementation plan exists. If yes, please write year of the most recent document.
Yes No 2007 MOH
3.01.08 Policy or group of policies on clinical laboratories exist. If yes, please write year of the most recent document in the "year" field
Yes No 2011 MOH
3.01.09 National clinical laboratory policy implementation plan exists. If yes, please write year of the most recent document in the "year" field
Yes No 2011 MOH
3.01.10 Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or
Yes No 2011 MOH
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national legislation?
3.01.11 There are official written guidelines on medicines donations.
Yes No WHO guidelines
3.01.12 Is pharmaceutical policy implementation being regularly monitored/assessed?
Yes No 2011 MOH
3.01.12.01 Who is responsible for pharmaceutical policy monitoring?
MOH
3.01.13 Is there a national good governance policy?
Yes No 2009 MOH
3.01.13.01 Multisectoral Yes
3.01.13.02 For the pharmaceutical sector
Yes 2009 MOH
3.01.13.03 Which agencies are responsible? Ministry of Health
3.01.14 A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs.
Yes No 2009 MOH
3.01.15 There is a formal code of conduct for public officials.
Yes No 2009 MOH
3.01.16 Is there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsperson)?
Yes No 2009 MOH
3.01.16.01 Please describe:
3.01.17 Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 4 Medicines Trade and Production
1.00 Respondent Information Section 4
4.00.01 Name of person responsible for filling out this section of the instrument
Dr. Rita Karam
4.00.02 Phone number 00961-1-615743
4.00.03 Email address ritakmouawad@hotmail.com
4.00.04 Other respondents for filling out this section
1.01 Intellectual Property Laws and Medicines
Core questions (click here for help)
Year Source
4.01.01 Country is a member of the World Trade Organization
Yes No WTO
4.01.02 Legal provisions provide for granting of Patents on:
Yes
4.01.02.01 Pharmaceuticals Yes No
4.01.02.02 Laboratory supplies Yes No
4.01.02.03 Medical supplies Yes No
4.01.02.04 Medical equipment Yes No
4.01.03.01 Please provide name and address of the institution responsible for managing and enforcing intellectual property rights
Ministry of Economy & Trade
4.01.03.02 Please provide URL
4.01.04 National Legislation has been modified to implement the TRIPS Agreement
Yes No
4.01.05 Current laws contain (TRIPS) flexibilities and safeguards
Yes No
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4.01.06 Country is eligible for the transitional period to 2016
Yes No
4.01.07 Which of the following (TRIPS) flexibilities and safeguards are present in the national law?
Yes
4.01.07.01 Compulsory licensing provisions that can be applied for reasons of public health
Yes No
4.01.07.02 Bolar exception Yes No
4.01.08 Are parallel importing provisions present in the national law?
Yes No
4.01.09 The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health
Yes No
4.01.10 Are there legal provisions for data exclusivity for pharmaceuticals
Yes No
4.01.11 Legal provisions exist for patent extension
Yes No
4.01.12 Legal provisions exist for linkage between patent status and Marketing Authorization
Yes No
4.01.13 Comments and References
4.02 Manufacturing
Core questions (click here for help)
Year Source
4.02.01 Number of licensed pharmaceutical manufacturers in the country
10 2011 MOH
4.02.02 Country has manufacturing capacity Yes
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4.02.02.01 R&D to discover new active substances
Yes No Unknown
4.02.02.02 Production of pharmaceutical starting materials (APIs)
Yes No Unknown
4.02.02.03 Production of formulations from pharmaceutical starting material
Yes No Unknown
4.02.02.04 Repackaging of finished dosage forms
Yes No Unknown
4.02.03 Percentage of market share by value produced by domestic manufacturers (%)
4.02.04 Comments and References
Supplementary questions (click here for help)
Year Source
4.02.05S Percentage of market share by volume produced by domestic manufacturers (%)
5 2011 MOH Data
4.02.06S Number of multinational pharmaceutical companies manufacturing medicines locally
25
4.02.07S Number of manufacturers that are Good Manufacturing Practice (GMP) certified
4.02.08S Comments and References
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Section 5 Medicines Regulation
5.00 Respondent Information Section 4
5.00.01 Name of person responsible for filling out this section of the instrument
Dr. Rasha Hamra
5.00.02 Phone number 00961-1-6115711
5.00.03 Email address rashahamra@yahoo.com
5.00.04 Other respondents for filling out this section
5.01 Regulatory Framework
Core questions (click here for help)
Year Source
5.01.01 Are there legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA)?
Yes No
5.01.02 There is a Medicines Regulatory Authority
Yes No 2011
MOH
5.01.03 If yes, please provide name and address of the Medicines regulatory authority
Ministry of Health in Lebanon
5.01.04 The Medicines Regulatory Authority is:
Yes
5.01.04.01 Part of MoH Yes
5.01.04.02 Semi autonomous agency Yes
5.01.04.03 Other (please specify)
5.01.05 What are the functions of the National Medicines Regulatory Authority?
Yes
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5.01.05.01 Marketing authorization / registration Yes No
5.01.05.02 Inspection Yes No
5.01.05.03 Import control Yes No
5.01.05.04 Licensing Yes No
5.01.05.05 Market control Yes No
5.01.05.06 Quality control Yes No
5.01.05.07 Medicines advertising and promotion Yes No
5.01.05.08 Clinical trials control Yes No
5.01.05.09 Pharmacovigilance Yes No
5.01.05.10 Other: (please explain)
5.01.06 Number of the MRA permanent staff 26 2011 MOH
5.01.06.01 Date of response
5.01.07 The MRA has its own website Yes No 2011 MOH
5.01.07.01 - If yes, please provide MRA Web site address (URL)
www.moph.gov.lb
5.01.08 The MRA receives external technical assistance
Yes No 2011 MOH
5.01.08.01 If yes, please describe: WHO, FSSAPS
5.01.09 The MRA is involved in harmonization/ collaboration initiatives
Yes No
5.01.09.01 - If yes, please specify
5.01.10 An assessment of the medicines regulatory system has been conducted in the last five years.
Yes No 2009 MOH
5.01.11 Medicines Regulatory Authority gets funds from regular budget of the
Yes No 2011 MOH
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government.
5.01.12 Medicines Regulatory Authority is funded from fees for services provided.
Yes No 2011 MOH
5.01.13 Medicines Regulatory Authority receives funds/support from other sources
Yes No 2011 MOH
5.01.13.01 - If yes, please specify
5.01.14 Revenues derived from regulatory activities are kept with the Regulatory
Authority
Yes No
5.01.15 The Regulatory Authority is using a computerized information management system to store and retrieve information on registration,
inspections, etc.
Yes No 2011 MOH
5.01.16 Comments and References
5.02 Marketing Authorization (Registration)
Core questions (click here for help)
Year Source
5.02.01 Legal provisions require a Marketing Authorization (registration) for all pharmaceutical products on the market
Yes No 1994 Pharmacy Law
5.02.02 Are there any mechanism for exception/waiver of registration?
Yes No 1994 Pharmacy Law
5.02.03 Are there mechanisms for recognition of registration done by other countries
Yes No 2011 MOH
5.02.03.01 If yes, please explain:
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5.02.04 Explicit and publicly available criteria exist for assessing applications for Marketing Authorization of pharmaceutical products
Yes No 2011 MOH
5.02.05 Information from the prequalification programme managed by WHO is used for product registration
Yes No 2011 MOH
5.02.06 Number of pharmaceutical products registered in your country
6045
5.02.07 Legal provisions require the MRA to make the list of registered pharmaceuticals with defined periodicity publicly available
Yes No 1994 Pharmacy Law
5.02.07.01 If yes, how frequently updated
2 weeks
5.02.07.02 If yes, please provide updated list or URL *
available on www.moph.gov.lb
5.02.08 Medicines registration always includes the INN (International Non-proprietary Names)
Yes No 2011 MOH
5.02.09 Legal provisions require the payment of a fee for Medicines Marketing Authorization (registration) applications
Yes No 1994 Pharmacy Law
5.02.10 Comments and References
Supplementary questions (click here for help)
Year Source
5.02.11S Legal provisions require Marketing Authorization holders to provide information about variations to the existing Marketing Authorization
Yes No 2008 Registration Law
5.02.12S Legal provisions require publication of a Summary of Product Characteristics (SPCs) of the
Yes No 2011 MOH
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medicines registered
5.02.13S Legal provisions require the establishment of an expert committee involved in the marketing authorization process
Yes No 1994 Pharmacy Law
5.02.14S Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the Marketing Authorization application
Yes No 2011 MOH
5.02.15S Legal provisions require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration
Yes No 2011 MOH
5.02.16S Legal provisions allow applicants to appeal against MRAs decisions
Yes No 2011 MOH
5.02.17S Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity (NCE) (US$)
2,350 2011 MOH
5.02.18S Registration fee - the Amount per application for a generic pharmaceutical product (US$)
2,350 2011 MOH
5.02.19S Time limit for the assessment of a Marketing Authorization application (months)
6
5.02.20S Comments & References
5.03 Regulatory Inspection
Core Questions(click here for help)
Year Source
5.03.01 Legal provisions exist allowing for appointment of government
Yes No 1994 Pharmacy Law
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pharmaceutical inspectors
5.03.02 Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed
Yes No 1994 Pharmacy Law
5.03.02.01 If yes, legal provisions exist requiring inspections to be performed
Yes No
5.03.03 Inspection is a pre-requisite for licensing of:
Yes
1994 Pharmacy Law
5.03.03.01 Public facilities Yes No
5.03.03.02 Private facilities Yes No
5.03.04 Inspection requirements are the same for public and private facilities
Yes No
5.03.05.01 Local manufactures are inspected for GMP compliance
Yes No
5.03.05.02 Private wholesalers are inspected Yes No
5.03.05.03 Retail distributors are inspected Yes No
5.03.05.04 Public pharmacies and stores are inspected
Yes No
5.03.05.05 Pharmacies and dispensing points of health facilities are inspected
Yes No
5.03.05.06 Please provide details on frequency of inspections for the different categories of facilities
At least Twice per year
5.03.06 Comments and References
5.04 Import Control
Core Questions (click here for help)
Year Source
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5.04.01 Legal provisions exist requiring authorization to import medicines
Yes No 1994 Pharmacy Law
5.04.02 Legal provisions exist allowing the sampling of imported products for testing
Yes No 1994 Pharmacy Law
5.04.03 Legal provisions exist requiring importation of medicines through authorized ports of entry
Yes No 1994 Pharmacy Law
5.04.04 Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized ports of entry
Yes No 1994 Pharmacy Law
5.04.05 Comments and References
5.05 Licensing
Year Source
5.05.01 Legal provisions exist requiring manufacturers to be licensed
Yes No 1994 Pharmacy Law
5.05.02 Legal provisions exist requiring both domestic and international manufacturers to comply with Good manufacturing Practices (GMP)
Yes No
5.05.02.01 If no, please explain
5.05.03 GMP requirements are published by the government.
Yes No 2010 MOH
5.05.04 Legal provisions exist requiring importers to be licensed
Yes No 1994 Pharmacy Law
5.05.05 Legal provisions exist requiring wholesalers and distributors to be licensed
Yes No 1994 Pharmacy Law
5.05.06 Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing
Yes No
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Practices
When filling in this part, please also fill in the relevant questions in the procurement and distribution section (Section 7)
5.05.07 National Good Distribution Practice requirements are published by the government
Yes No
5.05.08 Legal provisions exist requiring pharmacists to be registered
Yes No 1994 Pharmacy Law
5.05.09 Legal provisions exists requiring private pharmacies to be licensed
Yes No 1994 Pharmacy Law
5.05.10 Legal provision exist requiring public pharmacies to be licensed
Yes No 1994 Pharmacy Law
5.05.11 National Good Pharmacy Practice Guidelines are published by the government
Yes No
5.05.12 Legal provisions require the publication of a list of all licensed pharmaceutical facilities
Yes No
5.05.13 Comments and References
5.06 Market Control and Quality Control
Core Questions (click here for help)
Year Source
5.06.01 Legal Provisions for regulating the pharmaceutical market exist
Yes No 1994 Pharmacy Law
5.06.02 Does a laboratory exist in the country for Quality Control testing?
Yes No 2011 MOH
5.06.02.01 If yes, is the laboratory part of the MRA?
Yes No
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5.06.02.02 Does the regulatory authority contract services elsewhere?
Yes No
5.06.02.03 If yes, please describe Local Laboratories related to school of pharmacies in the country
5.06.03 Is there any national laboratory accepted for collaboration with WHO prequalification Programme? Please describe.
5.06.04 Medicines are tested:
s
5.06.04.01 For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities)
Yes No
5.06.04.02 For quality monitoring in private sector (routine sampling in retail outlets)
Yes No
5.06.04.03 When there are complaints or problem reports
Yes No
5.06.04.04 For product registration Yes No
5.06.04.05 For public procurement prequalification
Yes No
5.06.04.06 For public program products prior to acceptance and/or distribution
Yes No
5.06.05 Samples are collected by government inspectors for undertaking post-marketing surveillance testing
Yes No 1994 Pharmacy Law
5.06.06 How many Quality Control samples were taken for testing in the last two years?
5.06.07 Total number of samples tested in the last two years that failed to meet quality standards
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5.06.08 Results of quality testing in past two years are publicly available
Yes No
5.06.09 Comments and References
5.07 Medicines Advertising and Promotion
Core Questions (click here for help)
Year Source
5.07.01 Legal provisions exist to control the promotion and/or advertising of prescription medicines
Yes No 1994 Pharmacy Law
5.07.02 Who is responsible for regulating, promotion and/or advertising of medicines? Please describe:
Ministry of Health and Order of Pharmacists
5.07.03 Legal provisions prohibit direct advertising of prescription medicines to the public
Yes No 1994 Pharmacy Law
5.07.04 Legal provisions require a pre-approval for medicines advertisements and promotional materials
Yes No 1994 Pharmacy Law
5.07.05 Guidelines/Regulations exist for advertising and promotion of non-prescription medicines
Yes No 1994 Pharmacy Law
5.07.06 A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available
Yes No 2011 MOH
A draft under
revision
5.07.06.01 If yes, the code of conduct applies to domestic manufacturers only, multinational manufacturers only, or both
Yes No
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Domestic only Yes
Multinational only Yes
Both Yes
5.07.06.02 If yes, adherence to the code is voluntary
Yes No
5.07.06.03 If yes, the code contains a formal process for complaints and sanctions
Yes No
5.07.06.04 If yes, list of complaints and sanctions for the last two years is publicly available
Yes No
5.07.07 Comments and References
5.08 Clinical trials
Core Questions (click here for help)
Year Source
5.08.01 Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA
Yes No 2011 MOH
5.08.02 Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed
Yes No 2011 MOH
5.08.03 Legal provisions exist requiring registration of the clinical trials into international/national/regional registry
Yes No 2011 MOH
5.08.04 Comments and References
Supplementary questions (click here for help)
Year Source
5.08.05S Legal provisions exist for GMP compliance of investigational products
Yes No
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5.08.06S Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP)
Yes No
5.08.07S National GCP regulations are published by the Government.
Yes No
5.08.08S Legal provisions permit inspection of facilities where clinical trials are performed
Yes No
5.08.09S Comments and References
5.09 Controlled Medicines
Core Questions (click here for help)
Date Source
5.09.01 The country has adopted the following conventions:
Yes
5.09.01.01 Single Convention on Narcotic Drugs, 1961
Yes No 1965 International Narcotics
Control Board
5.09.01.02 The 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961
Yes No 1997 International Narcotics
Control Board
5.09.01.03 Convention on Psychotropic Substances 1971
Yes No 1994 International Narcotics
Control Board
5.09.01.04 United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988
Yes No 1996 International Narcotics
Control Board
5.09.02 Laws for the control of narcotic and psychotropic substances, and precursors exist
Yes No
Pharmaceutical Sector Country Profile Questionnaire.
31
5.09.03 Annual consumption of Morphine (mg/capita)
1.261637 2009 Narcotic Department-MOH
5.09.04 Comments and References Morphine: 5kg & 285g Total Consumption
Supplementary questions (click here for help)
Year Source
5.09.05S The legal provisions and regulations for the control of narcotic and psychotropic substances, and precursors have been reviewed by a WHO International Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need
Yes No Unknown 2010 MOH
5.09.05.01S If yes, year of review 2010
5.09.06S Annual consumption of Fentanyl (mg/capita)
0.0277464789 2009 Narcotic Department-MOH
5.09.07S Annual consumption of Pethidine (mg/capita)
3.21842922 2009 Narcotic Department-MOH
5.09.08S Annual consumption of Oxycodone (mg/capita)
0 2011 Narcotic Department-MOH
5.09.09S Annual consumption of Hydrocodone (mg/capita)
0 Narcotic Department-MOH
5.09.10S Annual consumption of Phenobarbital (mg/capita)
20.8689425 2009 Narcotic Department-MOH
5.09.11S Annual consumption of Methadone (mg/capita)
0 Narcotic Department-MOH
5.09.12S Comments and References Fentanyl: 116g & 230mg Total Consumption; Pethidine: 13kg &
Pharmaceutical Sector Country Profile Questionnaire.
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482g Total consumption,
Phenobarbital: 87kg & 420g Total consumption
5.09.05.01 Review 2010 March by INCB
5.10 Pharmacovigilance
Core Questions (click here for help)
Year Source
5.10.01 There are legal provision in the Medicines Act that provides for pharmacovigilance activities as part of the MRA mandate
Yes No 2011 MOH
5.10.02 Legal provisions exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA
Yes No
5.10.03 Legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country
Yes No
5.10.04 A national pharmacovigilance centre linked to the MRA exists in your country
Yes No
5.10.04.01 If a national pharmacovigilance centre exists in your country, how many staff does it employ full-time
5.10.04.02 If a national pharmacovigilance center exists in your country, an analysis report has been published in the last two years.
Yes No
5.10.04.03 If a national pharmacovigilance center exists in your country, it publishes an ADR bulletin
Yes No
Pharmaceutical Sector Country Profile Questionnaire.
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5.10.05 An official standardized form for reporting ADRs is used in your country
Yes No
5.10.06 A national Adverse Drug Reactions database exists in your country
Yes No
5.10.07 How many ADR reports are in the database?
5.10.08 How many reports have been submitted in the last two years?
5.10.09 Are ADR reports sent to the WHO database in Uppsala?
Yes No
5.10.09.01 If yes, number of reports sent in the last two years
5.10.10 Is there a national ADR or pharmacovigilance advisory committee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication?
Yes No
5.10.11 Is there a clear communication strategy for routine communication and crises communication?
Yes No
5.10.12 In the absence of a national pharmacovigilance system, ADRs are monitored in at least one public health program (for example TB, HIV, AIDS)?
Yes No
5.10.13 Please describe how you intend to enhance the Pharmacovigilance system
5.10.14 Comments and References
Supplementary questions (click here for help)
Pharmaceutical Sector Country Profile Questionnaire.
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Year Source
5.10.15S Feedback is provided to reporters Yes No
5.10.16S The ADR database is computerized Yes No
5.10.17S Medication errors (MEs) are reported Yes No
5.10.18S How many MEs are there in the ADRs database?
5.10.19S There is a risk management plan presented as part of product dossier submitted for Marketing Authorization?
Yes No
5.10.20S
In the past two years, who has reported ADRs?
Yes
5.10.20.01S Doctors Yes
5.10.20.02S Nurses Yes
5.10.20.03S Pharmacists Yes
5.10.20.04S Consumers Yes
5.10.20.05S Pharmaceutical Companies Yes
5.10.20.06S Others, please specify whom
5.10.21S Was there any regulatory decision based on local pharmacovigilance data in the last 2 years?
Yes No
5.10.22S Are there training courses in pharmacovigilance?
Yes No
5.10.22.01S If yes, how many people have been trained in the last two years?
5.10.23S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 6 Medicines Financing
6.00 Respondent Information Section 5
6.00.01 Name of person responsible for filling out this section of the instrument
Dr. Rasha Hamra & Dr. Coletter Raidy
6.00.02 Phone number 00961-1-615711
6.00.03 Email address rashahamra@yahoo.com, coletteraidy@hotmail.com
6.00.04 Other respondents for this sections
6.01 Medicines Coverage and Exemptions
Core Questions (click here for help)
Year Source
6.01.01 Do the followings receive medicines free of charge:
Yes 2011 MOH
6.01.01.01 Patients who cannot afford them Yes No
6.01.01.02 Children under 5 Yes No
6.01.01.03 Pregnant women Yes No
6.01.01.04 Elderly persons Yes No
6.01.01.05 Please describe/explain your yes answers for questions above
MOH is responsible to provide expensive medications to patients who do not have any formal health coverage (usually the poor and the unemployed). Also, MOH is responsible to provide vaccines for all children of Lebanon free of charge.
6.01.02 Is there a public health system or social health insurance scheme or public programme providing medicines free of charge for :
Yes
2011 MOH
6.01.02.01 All medicines included in the EML Yes No
6.01.02.02 Any non-communicable diseases Yes No
6.01.02.03 Malaria medicines Yes No
6.01.02.04 Tuberculosis medicines Yes No
Pharmaceutical Sector Country Profile Questionnaire.
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6.01.02.05 Sexually transmitted diseases medicines
Yes No
6.01.02.06 HIV/AIDS medicines Yes No
6.01.02.07 Expanded Program on Immunization (EPI) vaccines
Yes No
6.01.02.08 If others, please specify
6.01.02.09 Please describe/explain your yes answers for questions above
MOH is providing these medications free of charge for eligible patients
6.01.03 Does a national health insurance, social insurance or other sickness fund provide at least partial medicines coverage?
Yes No 2011 MOH
6.01.03.01 Does it provide coverage for medicines that are on the EML for inpatients
Yes No
6.01.03.02 Does it provide coverage for medicines that are on the EML for outpatients
Yes No
6.01.03.03 Please describe the medicines benefit of public/social insurance schemes
National Social Security Fund provide 85% of the cost of these medicines for people enrolled in this scheme.
6.01.04 Do private health insurance schemes provide any medicines coverage?
Yes No
6.01.04.01 If yes, is it required to provide coverage for medicines that are on the EML?
Yes No
6.01.05 Comments and References
6.02 Patients Fees and Copayments
Core Questions (click here for help)
Year Source
6.02.01 In your health system, at the point of delivery, are there any co-
Yes No
Pharmaceutical Sector Country Profile Questionnaire.
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payment/fee requirements for consultations
6.02.02 In your health system, at the point of delivery, are there any co-payment/fee requirements for medicines
Yes No
6.02.03 In practice, (even though this may be contrary to regulations) is revenue from fees or sales of medicines sometimes used to pay the salaries or supplement the income of public health personnel in the same facility?
Yes No
6.02.03.01 Please describe the patient fees and copayments system
6.02.04 Comments and References
6.03 Pricing Regulation for the Private Sector
Core Questions (click here for help)
Year Source
6.03.01 Are there legal or regulatory provisions affecting pricing of medicines
Yes No 2006 Pricing Decree 306/1 &
51/1
6.03.01.01 If yes, are the provisions aimed at Manufacturers
Yes No
6.03.01.02 If yes, are the provisions aimed at Wholesalers
Yes No
6.03.01.03 If yes, are the provisions aimed at Retailers
Yes No
6.03.01.04 Please explain the positive answers above: (explain scope of provisions i.e generics vs. originator or subsets of medicines, EML etc.)
Pharmaceutical Sector Country Profile Questionnaire.
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6.03.02 Government runs an active national medicines price monitoring system for retail prices
Yes No
6.03.03 Regulations exists mandating that retail medicine price information should be publicly accessible
Yes No
6.03.03.01 -if yes, please explain how the information is made publically available
List of Prices are published at the MOH website
www.moph.gov.lb
6.03.04 Comments and References
6.04 Prices, Availability and Affordability
Core Questions (click here for help)
Year Source
6.04.01-04 Please state if a medicines price survey using the WHO/HAI methodology has been conducted in the past 5 years in your country.
If yes, please indicate the year of the survey and use the results to fill in this table If no, but other surveys on medicines prices and availability have been conducted, please do not use them to fill in this section, but rather use the comment box to write some of the results and attach the report to the questionnaire
Yes No Unknown 2004 WHO/HAI Surveys of medicine prices and availability
Basket Of key medicines Public procurement Public patient Private
patient
Availability (one or both of)
Mean (%)
Orig 6.04.01.01
6.04.01.03
LPG 6.04.01.02
6.04.01.04
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Median (%)
Orig 6.04.02.01
6.04.02.03
LPG 6.04.02.02
0
6.04.02.04
83.8
Price Median Price Ratio
Orig 6.04.03.01
6.04.03.03
6.04.03.05
LPG 6.04.03.02
6.04.03.04
6.04.03.06
6.1
Affordability
Days’ wages of the lowest paid govt worker for standard treatment with co-trimoxazole for a child respiratory infection
Number of days’ wages
Orig 6.04.04.01
6.04.04.03
LPG 6.04.04.02
6.04.04.04
6.04.05 Comments and References
6.05 Price Components and Affordability
Core Questions (click here for help)
Year Source
6.05.01 Please state if a survey of medicines price components has been conducted in the past 5 years in your country
Yes No Unknown
2011 MOH
Repricing of all
registered products are done every 5 years
6.05.02 Median cumulative percentage mark-up between Manufacturer Selling Price (MSP)/ Cost Insurance and Freight (CIF) price and final medicine price for a basket of key medicines in the public sector (Median %
Pharmaceutical Sector Country Profile Questionnaire.
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contribution)
6.05.03 Median cumulative percentage mark-up between MSP/CIF price and final medicine price for a basket of key medicines in the private sector (Median % contribution)
6.05.04 Comment and References
Supplementary questions (click here for help)
6.05.05S Median percentage contribution of MSP/CIF to final medicine price for a basket of key medicines in the public sector (Median % contribution)
6.05.06S Median percentage contribution of MSP/CIF to final medicine price for a basket of key medicines in the private sector (Median % contribution)
6.05.07S Median manufacturer selling price (CIF) as percent of final medicine price for a basket of key medicines (%)
6.05.08S Median wholesaler selling price as percent of final medicine price for a basket of key medicines (%)
6.05.09S Median pharmacist mark-up or dispensing fee as percent of retail price for a basket of key medicines (%)
6.05.10S Median percentage contribution of the wholesale mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)
6.05.11S Median percentage contribution of the retail mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)
Pharmaceutical Sector Country Profile Questionnaire.
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6.05.12S Comment and References
6.06 Duties and Taxes on Pharmaceuticals (Market)
Core Questions (click here for help)
Year Source
6.06.01 There are duties on imported active pharmaceutical ingredients (APIs)
Yes No 2011 MOH
6.06.02 There are duties on imported finished products
Yes No 2011 MOH
6.06.03 VAT (value-added tax) or any other tax is levied on finished pharmaceuticals products
Yes No 2011 MOH
6.06.04 There are provisions for tax exceptions or waivers for pharmaceuticals and health products
Yes No 2011 MOH
6.06.05 Please specify categories of pharmaceuticals on which the taxes are applied and describe the exemptions and waivers that exist
6.06.06 Comments and References
Supplementary questions (click here for help)
Year Source
6.06.07S Duty on imported active pharmaceutical ingredients, APIs (%)
0 2011 MOH
6.06.08S Duty on imported finished products (%)
5 2011 MOH
6.06.09S VAT on pharmaceutical products (%) 5 2011 MOH
6.06.10S Comments and References 6.06.09S: 5% for drugs, 10% for products similar to drugs
Pharmaceutical Sector Country Profile Questionnaire.
Section 7 Pharmaceutical procurement and distribution
7.00 Respondent Information Section 6
7.00.01 Name of person responsible for filling out this section of the instrument
Dr. Rasha Hamra
7.00.02 Phone number 00961-1-615711
7.00.03 Email address rashahamra@yahoo.com
7.00.04 Other respondents for filling out this section
7.01 Public Sector Procurement
Core Questions (click here for help)
Date Source
7.01.01 Public sector procurement is:
Yes 2011 MOH
7.01.01.01 Decentralized
Yes
7.01.01.02 Centralized and decentralized
Yes
7.01.01.03 Please describe
7.01.02 If public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which
is:
Yes
2011 MOH
7.01.02.01 Part of MoH Yes No
7.01.02.02 Semi-Autonomous Yes No
7.01.02.03 Autonomous Yes No
Pharmaceutical Sector Country Profile Questionnaire.
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7.01.02.04 A government procurement agency which procures all public goods
Yes No
7.01.03 Public sector requests for tender documents are publicly available
Yes No 2011 MOH
7.01.04 Public sector tender awards are publicly available
Yes No 2011 MOH
7.01.05 Procurement is based on prequalification of suppliers
Yes No
7.01.05.01 If yes, please describe how it works
7.01.06 Comments and References
Supplementary questions (click here for help)
Year Source
7.01.07S Is there a written public sector procurement policy?. If yes, please write the year of approval in the "year" field
Yes No MOH
7.01.08S Are there legal provisions giving priority in public procurement to goods produced by local manufacturers?
Yes No
7.01.09S The key functions of the procurement unit and those of the tender committee are clearly separated
Yes No 2011 MOH
7.01.10S A process exists to ensure the quality of products procured
Yes No
7.01.10.01S If yes, the quality assurance process includes pre-qualification of products and suppliers
Yes No
7.01.10.02S If yes, explicit criteria and procedures exist for pre-qualification of suppliers
Yes No
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7.01.10.03S If yes, a list of pre-qualified suppliers and products is publicly available
Yes No
7.01.11S List of samples tested during the procurement process and results of quality testing are available
Yes No
7.01.12S Which of the following tender methods are used in public sector procurement:
Yes
7.01.12.01S National competitive tenders Yes No
7.01.12.02S International competitive tenders Yes No
7.01.12.03S Direct purchasing Yes No
7.01.13S Comments and References
7.02 Public Sector Distribution
Core Questions (click here for help)
Year Source
7.02.01 The government supply system department has a Central Medical Store at National Level
Yes No 2011 MOH
7.02.02 Number of public warehouses in the secondary tier of public distribution (State/Regional/Provincial)
5 2011 MOH
7.02.03 There are national guidelines on Good Distribution Practices (GDP)
Yes No MOH
7.02.04 There is a licensing authority that issues GDP licenses
Yes No
7.02.04.01 If a licensing authority exists, does it accredit public distribution
Yes No
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facilities?
7.02.05 List of GDP certified warehouses in the public sector exists
Yes No MOH
7.02.06 List of GDP certified distributors in the public sector exists
Yes No
7.02.07 Comments and References
Supplementary questions (click here for help)
Year Source
7.02.08S Which of the following processes is in place at the Central Medical Store:
Yes
2011 MOH
7.02.08.01S Forecasting of order quantities Yes No
7.02.08.02S Requisition/Stock orders Yes No
7.02.08.03S Preparation of picking/packing slips Yes No
7.02.08.04S Reports of stock on hand Yes No
7.02.08.05S Reports of outstanding order lines Yes No
7.02.08.06S Expiry dates management Yes No
7.02.08.07S Batch tracking Yes No
7.02.08.08S Reports of products out of stock Yes No
7.02.09S Percentage % availability of key medicines at the Central Medical Store
7.02.10S Average stock-out duration for a basket of medicines at the Central Medical Store, in days
7.02.11S Routine Procedure exists to track the expiry dates of medicines at the Central Medical Store
Yes No 2011 MOH
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7.02.12S The Public Central Medical Store is GDP certified by a licensing authority
Yes No
7.02.13S The Public Central Medical Store is ISO certified
Yes No
7.02.14S The second tier public warehouses are GDP certified by a licensing authority
Yes No
7.02.15S The second tier public warehouses are ISO certified
Yes No
7.02.16S Comments and References
7.03 Private Sector Distribution
Core Questions (click here for help)
Year Source
7.03.01 Legal provisions exist for licensing wholesalers in the private sector
Yes No 1994 Pharmacy Law
7.03.02 Legal provisions exist for licensing distributors in the private sector
Yes No 1994 Pharmacy Law
7.03.03 List of GDP certified wholesalers in the private sector exists
Yes No
7.03.04 List of GDP certified distributors in the private sector exists
Yes No
7.03.05 Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 8 Selection and rational use
8.00 Respondent Information Section 7
8.00.01 Name of person responsible for filling out this section of the instrument
Dr. Walid Ammar
8.00.02 Phone number
8.00.03 Email address mphealth@cyberia.net.lb
8.00.04 Other respondents for filling out this section
8.01 National Structures
Core Questions (click here for help)
Year Source
8.01.01 National essential medicines list (EML) exists. If yes, please write year of last update of EML in the "year" field
Yes No 2010 MOH
8.01.01.01 If yes, number of medicines on the EML (no. of INN)
8.01.01.02 If yes, there is a written process for selecting medicines on the EML
Yes No
8.01.01.03 If yes, the EML is publicly available Yes No
8.01.01.04 If yes, is there any mechanism in place to align the EML with the Standard Treatment Guidelines (STG)
Yes No
8.01.02 National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. If yes, please insert year of last update of STGs in the "year" field
Yes No 2010 MOH
8.01.03 STGs specific to Primary care exist. Please use the "year" field to
Yes No 2011 MOH
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write the year of last update of primary care guidelines
8.01.04 STGs specific to Secondary care (hospitals) exists. Please use the "year" field to write the year of last update of secondary care STGs.
Yes No Developed at Hospital Level
8.01.05 STGs specific to Paediatric conditions exist. Please use the "year" field to write the year of last update of paediatric condition STGs
Yes No
8.01.06 % of public health facilities with copy of EML (mean)- Survey data
8.01.07 % of public health facilities with copy of STGs (mean)- Survey data
8.01.08 A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers
Yes No 2011 Order of Pharmacist
s-DIC
8.01.09 Public education campaigns on rational medicine use topics have been conducted in the previous two years
Yes No
8.01.10 A survey on rational medicine use has been conducted in the previous two years
Yes No
8.01.11 A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of medicines
Yes No 2011 MOH
8.01.12 A written National strategy exists to contain antimicrobial resistance. If yes, please write year of last update of the strategy in the "year"
Yes No 2011 MOH
Pharmaceutical Sector Country Profile Questionnaire.
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field
8.01.13 Comments and References
Supplementary questions (click here for help)
Year Source
8.01.14S The Essential Medicines List (EML) includes formulations specific for children
Yes No
8.01.15S There are explicitly documented criteria for the selection of medicines in the EML
Yes No
8.01.16S There is a formal committee or other equivalent structure for the selection of products on the National EML
Yes No 2010 MOH
8.01.16.01S If yes, conflict of interest declarations are required from members of national EML committee
Yes No
8.01.17S National medicines formulary exists Yes No 2011 MOH
8.01.18S Is there a funded national inter-sectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection?
Yes No
8.01.19S A national reference laboratory/or any other institution has responsibility for coordinating epidemiological surveillance of antimicrobial resistance
Yes No
8.01.20S Comments and References
8.02 Prescribing
Core Questions (click here for help)
Pharmaceutical Sector Country Profile Questionnaire.
50
Year Source
8.02.01 Legal provisions exist to govern the licensing and prescribing practices of prescriber
Yes No
8.02.02 Legal provisions exist to restrict dispensing by prescribers
Yes No
8.02.03 Do prescribers in the private sector dispense medicines?
Yes No
8.02.04 Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs)
Yes No
8.02.05 Do more than half of referral hospitals have a DTC?
Yes No Unknown
8.02.06 Do more than half of general hospitals have a DTC?
Yes No Unknown
8.02.07 Do more than half of regions/provinces have a DTC?
Yes No Unknown
8.02.08 The core medical training curriculum includes components on:
Yes
8.02.08.01 Concept of EML Yes No
8.02.08.02 Use of STGs Yes No
8.02.08.03 Pharmacovigilance Yes No
8.02.08.04 Problem based pharmacotherapy Yes No
8.02.09 Mandatory continuing education that includes pharmaceutical issues is required for doctors (see physician)
Yes No
8.02.10 Mandatory continuing education that includes pharmaceutical issues is required for nurses
Yes No
Pharmaceutical Sector Country Profile Questionnaire.
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8.02.11 Mandatory continuing education that includes pharmaceutical issues is required for paramedical staff
Yes No
8.02.12 Prescribing by INN name is obligatory in:
Yes
8.02.12.01 Public sector Yes No
8.02.12.02 Private sector Yes No
8.02.13 Average number of medicines prescribed per patient contact in public health facilities (mean)
8.02.14 % of medicines prescribed in outpatient public health care facilities that are in the national EML (mean)
8.02.15 % of medicines in outpatient public health care facilities that are prescribed by INN name (mean)
8.02.16 % of patients in outpatient public health care facilities receiving antibiotics (mean)
8.02.17 % of patients in outpatient public health care facilities receiving injections (mean)
8.02.18 % of prescribed drugs dispensed to patients (mean)
8.02.19 % of medicines adequately labeled in public health facilities (mean)
8.02.20 Comments and References
Supplementary questions (click here for help)
Year Source
8.02.21S A professional association code of conduct exists governing
Yes No 2011 Order of
Pharmaceutical Sector Country Profile Questionnaire.
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professional behaviour of doctors Physicians
8.02.22S A professional association code of conduct exists governing professional behaviour of nurses
Yes No
8.02.23S Diarrhoea in children treated with Oral Rehydration Solution (ORS) (%)
8.02.24S Comments and References
8.03 Dispensing
Core Questions (click here for help)
Year Source
8.03.01 Legal provisions exist to govern dispensing practices of pharmaceutical personnel
Yes No 1994 Pharmacy Law
8.03.02 The basic pharmacist training curriculum includes components on:
Yes
8.03.02.01 Concept of EML Yes No
8.03.02.02 Use of STGs Yes No
8.03.02.03 Drug Information Yes No
8.03.02.04 Clinical pharmacology Yes No
8.03.02.05 Medicines supply management Yes No
8.03.03 Mandatory continuing education that includes rational use of medicines is required for pharmacists
Yes No
8.03.04 Generic substitution at the point of dispensing in public sector facilities is allowed
Yes No 2011 MOH
Pharmaceutical Sector Country Profile Questionnaire.
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8.03.05 Generic substitution at the point of dispensing in private sector facilities is allowed
Yes No 2011 MOH
8.03.06 In practice, (even though this may be contrary to regulations) are antibiotics sometimes sold over-the-counter without any prescription?
Yes No Unknown
8.03.07 In practice, (even though this may be contrary to regulations) are injections sometimes sold over-the-counter without any prescription?
Yes No Unknown
8.03.08 Comments and References
Supplementary questions (click here for help)
Year Source
8.03.09S A professional association code of conduct exists governing professional behaviour of pharmacists
Yes No 2011 Order of Pharmacists
8.03.10S In practice, (even though this may be contrary to regulations) do the following groups of staff sometimes prescribe prescription-only medicines at the primary care level in the public sector?
Yes
8.03.10.01S Nurses Yes No Unknown
8.03.10.02S Pharmacists Yes No Unknown
8.03.10.03S Paramedics Yes No Unknown
8.03.10.04S Personnel with less than one month training
Yes No Unknown
8.03.11S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Section 9 Household data/access
9.00 Respondent Information section 8
9.00.01 Name of person responsible for filling out this section of the instrument
9.00.02 Phone number
9.00.03 Email address
9.00.04 Other respondents for filling out this section
9.01 Data from Household Surveys
Core Questions (click here for help)
Year Source
9.01.01 What household surveys have been undertaken in the past 5 years to assess access to medicines?
9.01.02 Adults with acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)
9.01.03 Adults with acute conditions not taking all medicines because they cannot afford them (%)
9.01.04 Adults (from poor households) with an acute health condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)
9.01.05 Adults (from poor households) with an acute condition in two-week recall period who did not take all medicines because they cannot afford them (%)
Pharmaceutical Sector Country Profile Questionnaire.
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9.01.06 Adults with chronic conditions taking all medicines prescribed by an authorized prescriber (%)
9.01.07 Adults (from poor households) with chronic conditions not taking all medicines because they cannot afford them (%)
9.01.08 Adults (from poor households) with chronic conditions who usually take all medicines prescribed by an authorized prescriber (%)
9.01.09 Children (from poor households) with an acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)
9.01.10 Percentage of people who obtained the medicines prescribed in the 15 days before the interview (%)
9.01.11 People who obtained prescribed medicines for free in the 15 days before the interview (%)
9.01.12 Comments and References
Supplementary questions (click here for help)
Year Source
9.01.13S Adults with acute conditions not taking all medicines because the medicines were not available (%)
9.01.14S Adults with chronic conditions not taking all medicines because they cannot afford them (%)
9.01.15S Adults with chronic conditions not taking all medicines because the medicines were not available (%)
Pharmaceutical Sector Country Profile Questionnaire.
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9.01.16S Children with acute conditions taking all medicines prescribed by an authorized prescriber (%)
9.01.17S Children with acute conditions not taking all medicines because they cannot afford them (%)
9.01.18S Children with acute conditions not taking all medicines because the medicines were not available (%)
9.01.19S Children (from poor households) with acute conditions not taking all medicines because they cannot afford them (%)
9.01.20S Comments and References
Pharmaceutical Sector Country Profile Questionnaire.
Key Documents to be attached
Document Exact title Author Publisher Year File name National Medicines Policy (NMP)
NMP implementation plan National Medicines Act National pharmaceutical human resources report or strategic plan
Latest report on the national pharmaceutical market (any source)
National Pharmacovigilance Centre report (including Adverse Drug Reaction, ADR, analysis report in the last two years)
National pharmaceutical legislation for regulation
Annual report of quality control laboratories
Annual report of national regulatory authority
Legal provisions on medicines price regulations
Medicines procurement policy
National Essential Medicines List (EML)
National Standard Treatment Guidelines (STGs)
National Strategy for anti-microbial resistance
Any other medicines